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Treatment of Disseminated High Grade Lymphoma

This study has been completed.
Information provided by:
French Innovative Leukemia Organisation Identifier:
First received: September 26, 2007
Last updated: October 31, 2007
Last verified: September 2007
Interest of the use of pegylated liposomal doxorubicin (caélyx)

Condition Intervention Phase
Lymphoma Drug: Doxorubicin Drug: Doxorubicin pegylated Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study of Treatment of Disseminated and Agressive Lymphoma R CHOP Versus R CLOP( With Liposomal Doxorubicin)

Resource links provided by NLM:

Further study details as provided by French Innovative Leukemia Organisation:

Primary Outcome Measures:
  • hematologic toxicity [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • response rate [ Time Frame: 6 months ]
  • EFS and OS [ Time Frame: 6 months ]
  • Cardiac toxicity [ Time Frame: 6 months ]

Enrollment: 100
Study Start Date: October 2000
Study Completion Date: October 2004
Arms Assigned Interventions
Active Comparator: Doxorubicine
CHOP 8 courses every 21 days
Drug: Doxorubicin
Experimental: Doxorubicine pegylated
CLOP 8 courses every 21 days
Drug: Doxorubicin pegylated

Detailed Description:
R CHOP is a good standard in the treatment of diffuse high grade lymphoma. Howeverin elderly patients it is often toxic, specially with haematologic and cardiac toxicities.

Ages Eligible for Study:   60 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • high grade lymphoma
  • disseminated
  • > 60 years old and < 75
  • informed consent signed
  • cardiac state compatible with antracyclin
  • ECOG </= 2

Exclusion Criteria:

  • patients > 75 years old
  • Cardiac insufficiency
  Contacts and Locations
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Please refer to this study by its identifier: NCT00536393

Clinique Victor Hugo
Le Mans, France, 72015
Sponsors and Collaborators
French Innovative Leukemia Organisation
Principal Investigator: Guillaume CARTRON, Dr French Innovative Leukemia Organisation
  More Information Identifier: NCT00536393     History of Changes
Other Study ID Numbers: GOELAMS 0804
Study First Received: September 26, 2007
Last Updated: October 31, 2007

Keywords provided by French Innovative Leukemia Organisation:
diffuse larg cells lymphoma
diffuse high grade lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 16, 2017